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Drug ReportsDapagliflozin
Farxiga, Forxiga(dapagliflozin)
Dapagliflozin, Ebymect, Edistride, Farxiga, Forxiga, Qtern, Qternmet, Qtrilmet, Xigduo (dapagliflozin) is a small molecule pharmaceutical. Dapagliflozin was first approved as Forxiga on 2012-11-11. It is used to treat type 2 diabetes mellitus in the USA. It has been approved in Europe to treat chronic renal insufficiency, diabetes mellitus, glucose metabolism disorders, heart failure, and metabolic diseases amongst others.
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Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
urogenital diseasesD000091642
cardiovascular diseasesD002318
nutritional and metabolic diseasesD009750
endocrine system diseasesD004700
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Farxiga (discontinued: Dapagliflozin)
Combinations
Xigduo (discontinued: Qtern, Qternmet)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Dapagliflozin
Tradename
Company
Number
Date
Products
FARXIGAAstraZenecaN-202293 RX2014-01-08
2 products, RLD, RS
Dapagliflozin
+
Saxagliptin hydrochloride
Tradename
Company
Number
Date
Products
QTERNAstraZenecaN-209091 DISCN2017-02-27
2 products, RLD
Hide discontinued
Dapagliflozin
+
Metformin hydrochloride
+
Saxagliptin hydrochloride
Tradename
Company
Number
Date
Products
QTERNMET XRAstraZenecaN-210874 DISCN2019-05-02
4 products, RLD
Hide discontinued
Dapagliflozin
+
Metformin hydrochloride
Tradename
Company
Number
Date
Products
XIGDUO XRAstraZenecaN-205649 RX2014-10-29
5 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
dapagliflozinNDA authorized generic2024-10-24
dapagliflozin and metformin hydrochlorideNDA authorized generic2024-12-20
farxigaNew Drug Application2024-10-24
qternNew Drug Application2024-11-13
xigduoNew Drug Application2024-12-20
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
type 2 diabetes mellitusEFO_0001360D003924E11
Agency Specific
FDA
EMA
Expiration
Code
DAPAGLIFLOZIN, FARXIGA, ASTRAZENECA AB
2024-04-30I-857
2023-05-05I-834
Patent Expiration
Patent
Expires
Flag
FDA Information
Dapagliflozin, Farxiga, Astrazeneca Ab
109738362040-03-09U-3127
86859342030-05-26U-1522
87216152030-01-18DP
79195982029-12-16DP
78515022028-08-19DP
82217862028-03-21DP
83619722028-03-21U-493, U-1976, U-1977, U-2139
87162512028-03-21DP
85016982027-06-20DPU-493, U-1976, U-1977
83296482026-08-18U-2139, U-2212, U-2213
89068512026-08-18U-2139
65151172025-10-04DS, DPU-493, U-2139
74562542025-06-30DPU-2139
84316852025-04-13DPU-2139
84611052025-04-13DPU-2139
92380762024-04-15DPU-2139
Dapagliflozin / Metformin Hydrochloride, Xigduo Xr, Astrazeneca Ab
96160282030-11-12DP
Dapagliflozin / Metformin Hydrochloride / Saxagliptin Hydrochloride, Qternmet Xr, Astrazeneca Ab
86287992025-07-13DP
RE441862023-07-31DS, DPU-493
ATC Codes
A: Alimentary tract and metabolism drugs
— A10: Drugs used in diabetes
— A10B: Blood glucose lowering drugs, excl. insulins
— A10BD: Combinations of oral blood glucose lowering drugs
— A10BD15: Metformin and dapagliflozin
— A10BD21: Saxagliptin and dapagliflozin
— A10BD25: Metformin, saxagliptin and dapagliflozin
— A10BK: Sodium-glucose co-transporter 2 (sglt2) inhibitors
— A10BK01: Dapagliflozin
HCPCS
No data
Clinical
Clinical Trials
674 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Type 2 diabetes mellitusD003924EFO_0001360E112310413420124
Diabetes mellitusD003920EFO_0000400E08-E135729201371
Heart failureD006333EFO_0003144I502293824
Chronic renal insufficiencyD051436—N1811062422
Kidney diseasesD007674EFO_0003086N0811041318
HypertensionD006973EFO_0000537I10—261—8
Type 1 diabetes mellitusD003922EFO_0001359E10213118
AlbuminuriaD000419EFO_0004285R80.9—312—5
Prediabetic stateD011236EFO_1001121R73.03—11215
ObesityD009765EFO_0001073E66.9—221—5
Show 23 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Body weightD001835EFO_0004338——21——3
Glucose metabolism disordersD044882————2——2
Metabolic diseasesD008659EFO_0000589E88.9——2——2
Endocrine system diseasesD004700EFO_0001379E34.9——2——2
Inferior wall myocardial infarctionD056989EFO_1000983———1——1
Covid-19D000086382—U07.1——1——1
Respiratory insufficiencyD012131—J96.9——1——1
Polycystic ovary syndromeD011085EFO_0000660E28.2——1——1
SyndromeD013577————1——1
DeathD003643PATO_0001422———1——1
Show 4 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Weight lossD015431———2———2
Liver cirrhosisD008103EFO_0001422K74.0—2———2
Diastolic heart failureD054144EFO_1000899I50.30—1———1
Asymptomatic diseasesD058070———1———1
HyperuricemiaD033461———1———1
GoutD006073EFO_0004274M10—1———1
ExerciseD015444EFO_0000483——1———1
Liver diseasesD008107EFO_0001421K70-K77—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———11————11
Therapeutic equivalencyD013810——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CardiomyopathiesD009202EFO_0000318I42————11
Diabetic cardiomyopathiesD058065EFO_1001458—————11
InfectionsD007239EFO_0000544—————11
Urinary tract infectionsD014552EFO_0003103N39.0————11
Breast neoplasmsD001943EFO_0003869C50————11
Urinary bladder neoplasmsD001749—C67————11
Wounds and injuriesD014947—T14.8————11
Chemical and drug induced liver injuryD056486EFO_0004228—————11
Acute kidney injuryD058186—N17————11
Systolic heart failureD054143EFO_1001207I50.20————11
Show 2 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDapagliflozin
INNdapagliflozin
Description
Dapagliflozin is a C-glycosyl comprising beta-D-glucose in which the anomeric hydroxy group is replaced by a 4-chloro-3-(4-ethoxybenzyl)phenyl group. Used (in the formo f its propanediol monohydrate) to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. It has a role as a hypoglycemic agent and a sodium-glucose transport protein subtype 2 inhibitor. It is a C-glycosyl compound, an organochlorine compound and an aromatic ether.
Classification
Small molecule
Drug classphlorozin derivatives, phenolic glycosides
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Identifiers
PDB—
CAS-ID461432-26-8
RxCUI—
ChEMBL IDCHEMBL429910
ChEBI ID85078
PubChem CID9887712
DrugBankDB06292
UNII ID1ULL0QJ8UC (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Farxiga – AstraZeneca
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Forxiga – Bristol Myers Squibb
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Qtern – AstraZeneca
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Tabular view
Estimated US medical usage
Dapagliflozin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 16,292 documents
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Safety
Black-box Warning
Black-box warning for: Dapagliflozin and metformin hydrochloride, Xigduo
Adverse Events
Top Adverse Reactions
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39,207 adverse events reported
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